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AzTrials

Prostate CancerPhase 2NCT00045227

Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine and recombinant vaccinia-B7.1 vaccine in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine and recombinant vaccinia-B7.1 vaccine
Type of treatment
Vaccines
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 2002to Oct 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of androgen-independent metastatic adenocarcinoma of the prostate, confirmed by 1 of the following:
  • Histologically confirmed disease
  • Pathologically documented disease and clinical course consistent with prostate cancer
  • Castrate levels of testosterone with progressive disease by at least 1 of the following parameters:
  • 2 consecutively rising prostate-specific antigen levels, separated by at least 1 week, with at least 1 measurement that is 50% above the nadir reached after the last therapeutic maneuver (must be at least 5 ng/mL)
  • At least 1 new metastatic deposit on technetium Tc 99 bone scintigraphy
  • Progression of soft-tissue metastases by imaging or palpation, as indicated by:
  • Development of new area of malignant disease
  • At least 20% increase in sum of the longest dimension of target lesions
  • Serum testosterone less than 50 ng/dL if no prior surgical castration
  • Luteinizing hormone-releasing hormone therapy must continue
  • HLA-A2 positive
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Lymphocyte count at least 500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin less than 1.5 mg/dL
  • AST and ALT less than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN OR
  • Hepatic alkaline phosphatase fraction less than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 40 mL/min
  • Proteinuria grade 0-1 OR
  • Protein less than 1,000 mg by 24-hour urine collection
  • No hematuria
  • No abnormal sediment unless non-renal

Cardiovascular

  • No unstable or newly diagnosed angina pectoris
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class II-IV congestive heart failure
  • No concurrent clinically significant cardiomyopathy requiring treatment

Immunologic

  • No prior allergy or untoward reaction to vaccinia virus vaccination
  • No altered immune function, including:
  • Eczema
  • Atopic dermatitis
  • HIV
  • Autoimmune disease
  • Autoimmune neutropenia
  • Thrombocytopenia
  • Hemolytic anemia
  • Systemic lupus erythematosus
  • Sjogren's syndrome
  • Scleroderma
  • Myasthenia gravis
  • Goodpasture syndrome
  • Addison's disease
  • Hashimoto's thyroiditis
  • Active Graves' disease
  • Multiple sclerosis
  • No extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition
  • No known allergy to eggs

Other

  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder
  • No other life-threatening or serious illness
  • No unhealed surgical scars
  • No household or close physical contact with persons with any of the following conditions during or for 2 weeks after study treatment:
  • Eczema or eczematoid skin disorders
  • Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • Pregnant or nursing women
  • Children under 5 years of age
  • Immunodeficient or immunosuppressed (including HIV positive) individuals
  • No history of seizures or encephalitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior taxanes for metastatic prostate cancer

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide
  • At least 6 weeks since prior bicalutamide or nilutamide
  • No concurrent steroids except topical steroids, inhaled steroids for mild or moderate asthma, or decadron as premedication for chemotherapy

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  • No prior splenectomy

Other

  • Recovered from prior therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Pilot Trial of Pox Vector PSA Vaccine With Concurrent Docetaxel Versus Pox Vector Vaccine Followed by Docetaxel in Metastatic Androgen Independent Prostate Cancer

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy with or without docetaxel in treating patients who have metastatic prostate cancer.

Read the detailed description

OBJECTIVES:

  • Compare the relative change in prostate-specific antigen (PSA)-specific T-cell precursors (CD8) from baseline to day 85 in patients with metastatic androgen-independent prostate cancer treated with a vaccination regimen comprising fowlpox-PSA vaccine, recombinant rV-B7.1 vaccine, recombinant vaccinia-PSA vaccine, and sargramostim (GM-CSF) with or without docetaxel.
  • Compare the safety of these regimens in these patients.
  • Compare clinical activity of these regimens in these patients.
  • Determine the immunologic effects in these patients after additional vaccine/chemotherapy courses.
  • Measure CD4 T-cell responses to the vaccine in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms after receiving priming vaccinations.

  • Priming vaccinations: All patients receive recombinant vaccinia-prostate-specific antigen (PSA) vaccine subcutaneously (SC) and recombinant rV-B7.1 vaccine SC on day 1 and sargramostim (GM-CSF) SC on days 1-4. Patients then receive fowlpox-PSA vaccine (F-PSA) SC on day 15 and GM-CSF SC on days 15-18.
  • Arm I: Patients receive docetaxel IV over 30 minutes on days 29, 36, and 43; F-PSA SC on day 30; and GM-CSF SC on days 30-33. Treatment repeats beginning on day 56 for one more course. Patients who do not have disease progression at day 85 receive docetaxel weekly for 3 weeks and F-PSA on day 1 of each course. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive F-PSA SC on days 29 and 57 and GM-CSF SC on days 29-32 and 57-60. Patients who show disease progression after day 85 either radiographically or by rising PSA stop receiving the vaccine and may receive docetaxel weekly for 3 weeks. Chemotherapy repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this study within 9-10 months.

Conditions
Prostate Cancer
Being tested
recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine, recombinant vaccinia-B7.1 vaccine, sargramostim, docetaxel
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant fowlpox-prostate specific antigen vaccineBiological

  • recombinant vaccinia prostate-specific antigen vaccineBiological

  • recombinant vaccinia-B7.1 vaccineBiological

  • sargramostimBiological

  • docetaxelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045227
Sponsor's protocol ID
CDR0000256919
Other IDs
NCI-02-C-0218, NCI-5319
Status last verified
Dec 2003
First submitted
6 Sep 2002
Last updated
19 Jun 2013
Results posted
No

Publications

  • Arlen PM, Gulley JL, Parker C, Skarupa L, Pazdur M, Panicali D, Beetham P, Tsang KY, Grosenbach DW, Feldman J, Steinberg SM, Jones E, Chen C, Marte J, Schlom J, Dahut W. A randomized phase II study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen-independent prostate cancer. Clin Cancer Res. 2006 Feb 15;12(4):1260-9. doi: 10.1158/1078-0432.CCR-05-2059.

    PubMed 16489082

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing recombinant fowlpox-prostate specific antigen vaccine, recombinant vaccinia prostate-specific antigen vaccine and recombinant vaccinia-B7.1 vaccine in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.

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